Overview

In this role you will lead verification and validation across cloud and mobile platforms within a regulated medical device environment. You will shape test strategies and ensure regulatory compliance to support scalable, high-quality releases for a general health platform. You’ll collaborate with product, architecture, development, and quality teams to translate requirements into verifiable tests and improve automation coverage. This is a mission-driven opportunity to advance digital health insights while embedding quality and compliance into the software lifecycle.

Responsabilidades

- Own and execute end-to-end software verification for cloud, mobile, and connected systems
- Translate requirements into verification strategies, test plans, and execution plans
- Develop and improve verification plans, protocols, and reports per FDA 21 CFR, ISO 13485, IEC 62304
- Collaborate with Product Managers, Architects, Developers, and Quality teams to ensure testable requirements
- Support risk management activities including risk analysis and root-cause investigations
- Participate in design reviews to verify inputs/outputs meet regulatory and quality expectations
- Design and implement scalable manual and automated testing across functional, integration, system,



and regression
- Contribute to test automation frameworks and CI/CD pipelines
- Drive continuous improvement of verification processes, tools, metrics, and automation coverage
- Mentor junior test engineers in engineering discipline and best practices

Requisitos principales

- Bachelor’s degree in software engineering, Computer Science, or related field, or equivalent practical experience
- 6+ years in software verification, software test engineering, or quality engineering
- 2+ years in medical device software development under FDA 21 CFR 820, ISO 13485, IEC 62304
- Strong expertise in medical device software V&V; including defect management and requirements traceability
- Experience identifying and implementing test automation opportunities across mobile, web, API, or similar platforms
- Experience with modern CI/CD ecosystems such as GitHub Actions, Azure Pipelines, or Harness
- Excellent analytical, communication, and documentation skills with a collaborative, quality-focused mindset

- collaborative
- analytical thinking
- strong communication
- test automation
- functional/integration/system/regression testing
- risk management

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